Regulatory Foundations, Ethics, and Law Program

Quality Assurance/Quality Improvement (QA/QI)

Drawing from expertise throughout Harvard Catalyst’s participating institutions, the Regulatory Foundations, Ethics, and Law program facilitates the development and strengthening of Quality Assurance/Quality Improvement (QA/QI) programs by educating the research community, enabling compliance, and collaborating around issues relating to regulatory compliance.

QA/QI functions ensure investigator and institutional compliance with federal and state regulations governing human research. This is accomplished by providing ongoing support, education and study management tools, and best practice recommendations that go above and beyond mere compliance, with an emphasis on improving efficiency.

Harvard Catalyst QA/QI Subcommittee

The Harvard Catalyst QA/QI Subcommittee includes recognized QA/QI leaders and IRB members from participating Harvard Catalyst institutions. The Subcommittee also engages those new to the regulatory compliance arena who offer fresh perspectives and novel approaches to a problem. Each member brings a range of experience and familiarity: from social behavioral to biomedical research, from single-site, local research to multi-center, international studies.

Harvard Catalyst Collaborative Quality
Improvement Program (CQIP)

The Collaborative Quality Improvement Program (CQIP) is a part of the Harvard Catalyst Regulatory Program which meets to help small institutions or human research protection programs (HRPP) develop their QA/QI activities.

Electronic Regulatory Binder Project

The eReg Binder is a REDCap project developed by the Mass General Brigham Human Research Quality Improvement (QI) Program and Enterprise Research Infrastructure & Services (ERIS). The eReg Binder assists sites with the electronic storage and maintenance of regulatory documents for IRB-approved protocols. The eReg Binder is available through the REDCap consortium.

• If you are interested in using the binder, please contact the REDCap Administrator at your institution to find out if the template is available for use.
• If you are a REDCap Administrator interested in adding the template to your environment, full instructions are available.

Harvard Catalyst QA/QI Consulting Service –  Request consult

Consultations offered to IRBs within the Harvard Catalyst community that lack QA/QI resources and/or necessary expertise.

Preparing for an FDA IRB Inspection Video

Video providing information about preparing for an FDA Institutional Review Board inspection, including what to expect on inspection day, pre- and post-inspection processes, common deficiencies, and points to consider.

To request any of the above documents be made accessible please email communications@catalyst.harvard.edu.